Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 3d9ed59f-f280-4cc2-a0f1-4180deb5b792
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (74 mg) Zinc Oxide (63 mg)
Inactive Ingredients
Water Dimethicone Butylene Glycol Dicaprylate/dicaprate Butylene Glycol Cyclomethicone 5 Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Butyloctyl Salicylate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Sodium Chloride Bis-diglyceryl Polyacyladipate-2 Aluminum Hydroxide Stearic Acid Disteardimonium Hectorite Sorbitan Isostearate Polyglyceryl-4 Isostearate Hexyl Laurate Triethoxycaprylylsilane Triethyl Citrate Ethohexadiol Sodium Benzoate Phenoxyethanol Potassium Sorbate Polymethylsilsesquioxane (4.5 Microns) .alpha.-tocopherol Acetate Edetate Disodium Oat Glycerin Niacinamide Turmeric Sulfur Cholesterol Chamaemelum Nobile Flower Oil Perflexane Avocado Maltodextrin 1,2-hexanediol Vitis Vinifera Seed Green Tea Leaf Salix Alba Bark Magnolia Kobus Bark Chrysanthemum Indicum Flower Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Soybean Perflunafene Aloe Vera Leaf Perfluoromethylcyclopentane Citric Acid Monohydrate Olea Europaea Leaf Artemisia Princeps Leaf Chinese Cinnamon Pueraria Montana Var. Lobata Root Diospyros Kaki Leaf White Mulberry Steareth-20 Melaleuca Alternifolia Flowering Top Pomegranate Juice Ethylhexylglycerin Activated Charcoal Chlorhexidine Gluconate N-hydroxysuccinimide Sodium Citrate Palmitoyl Tripeptide-1 Chrysin Palmitoyl Tetrapeptide-7 Biotin Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-01

Description

Titanium dioxide 7.4% Zinc oxide  6.3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 7.4% Zinc oxide  6.3%

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4

Warnings

For external use only

Directions

● shake well before use

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,

    regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

   ● limit time in the sun, especially from 10 a.m. – 2 p.m.

   ● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

protect the product in this container from excessive heat and direct sun

Active Ingredients

Titanium dioxide 7.4%

Zinc oxide  6.3%

Inactive Ingredients

water, dimethicone, butylene glycol dicaprylate/dicaprate, butylene glycol, cyclopentasiloxane, dimethicone/vinyl dimethicone crosspolymer, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, snail secretion filtrate, sodium chloride, bis-diglyceryl polyacyladipate-2, aluminum hydroxide, stearic acid, disteardimonium hectorite, sorbitan isostearate, polyglyceryl-4 isostearate, hexyl laurate, triethoxycaprylylsilane, triethyl citrate, ethyl hexanediol, sodium benzoate, phenoxyethanol, potassium sorbate, polymethylsilsesquioxane, tocopheryl acetate, disodium EDTA, canadian colloidal clay, moroccan lava clay, avena sativa (oat) kernel extract, glycerin, niacinamide, curcuma longa (turmeric) root extract, sulfur, cholesterol, anthemis nobilis flower water, perfluorohexane, persea gratissima (avocado) fruit extract, maltodextrin, 1,2-hexanediol, vitis vinifera (grape) seed extract, camellia sinensis leaf extract, salix alba (willow) bark extract, magnolia kobus bark extract, chrysanthemum indicum flower extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, aloe barbadensis leaf extract, perfluoromethylcyclopentane, citric acid, olea europaea (olive) leaf extract, artemisia princeps leaf extract, cinnamomum cassia bark extract, pueraria lobata root extract, diospyros kaki leaf extract, morus alba fruit extract, steareth-20, melaleuca alternifolia (tea tree) flower/leaf/stem extract, punica granatum fruit juice, hydrolyzed collagen, ethylhexylglycerin, charcoal powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7, biotin; may contain: iron oxides, titanium dioxide

Questions Or Comments?

Call 800-620-3956

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

● shake well before use

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk,

    regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

   ● limit time in the sun, especially from 10 a.m. – 2 p.m.

   ● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Active Ingredients (Active ingredients)

Titanium dioxide 7.4%

Zinc oxide  6.3%

Inactive Ingredients (Inactive ingredients)

water, dimethicone, butylene glycol dicaprylate/dicaprate, butylene glycol, cyclopentasiloxane, dimethicone/vinyl dimethicone crosspolymer, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, snail secretion filtrate, sodium chloride, bis-diglyceryl polyacyladipate-2, aluminum hydroxide, stearic acid, disteardimonium hectorite, sorbitan isostearate, polyglyceryl-4 isostearate, hexyl laurate, triethoxycaprylylsilane, triethyl citrate, ethyl hexanediol, sodium benzoate, phenoxyethanol, potassium sorbate, polymethylsilsesquioxane, tocopheryl acetate, disodium EDTA, canadian colloidal clay, moroccan lava clay, avena sativa (oat) kernel extract, glycerin, niacinamide, curcuma longa (turmeric) root extract, sulfur, cholesterol, anthemis nobilis flower water, perfluorohexane, persea gratissima (avocado) fruit extract, maltodextrin, 1,2-hexanediol, vitis vinifera (grape) seed extract, camellia sinensis leaf extract, salix alba (willow) bark extract, magnolia kobus bark extract, chrysanthemum indicum flower extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, glycine soja (soybean) sprout extract, perfluorodecalin, silk extract, hydrolyzed silk, aloe barbadensis leaf extract, perfluoromethylcyclopentane, citric acid, olea europaea (olive) leaf extract, artemisia princeps leaf extract, cinnamomum cassia bark extract, pueraria lobata root extract, diospyros kaki leaf extract, morus alba fruit extract, steareth-20, melaleuca alternifolia (tea tree) flower/leaf/stem extract, punica granatum fruit juice, hydrolyzed collagen, ethylhexylglycerin, charcoal powder, lactobacillus/honeysuckle flower/licorice root/morus alba root/pueraria lobata root/schisandra chinensis fruit/scutellaria baicalensis root/sophora japonica flower extract ferment filtrate, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, palmitoyl tripeptide-1, hydrolyzed hyaluronic acid, chrysin, palmitoyl tetrapeptide-7, biotin; may contain: iron oxides, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 800-620-3956

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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